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Efficacy and Safety of Imotun Capsule in Osteoarthritis of the Knee (ABSOLUTE-R)

Primary Purpose

Osteoarthritis of the Knee

Status
Completed
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Imotun
Placebo
Sponsored by
Chong Kun Dang Pharmaceutical
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoarthritis of the Knee focused on measuring osteoarthritis of the knee

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Agreement with written informed consent and 40 years of age and older
  • Patients with more than 63months history of OA of knee according to ACR criteria
  • Radiographic evidence of Kellgren & Lawrence grade II to III OA of the knee
  • The 100mm Pain VAS is over 40mm
  • The Lequensne's index is over 5

Exclusion Criteria:

  • Treatment with SYSADOA within 3 months
  • History of joint surgery within 5 years or Arthroscopic surgery within 1year
  • Intra-articular injections within 3 months
  • Treatment with NASIDs within 7 days
  • Any history of adverse reaction to the study drugs
  • clinically significant hepatic, renal, cardiovascular diseases
  • Patients with gastrointestinal ulcers or bleeding disorders
  • Pregnant women, nursing mothers or Fertile women who not practice contraception with appropriate methods
  • History of drug abuse or alcoholism
  • Patients on any other clinical trial or experimental treatment in the past 4 weeks
  • An impossible one who participates in clinical trial by investigator's decision

Sites / Locations

  • Hallym Universicy Sacred heart Hospital
  • Dong-A university Hospital
  • Yeungnam university medical center
  • Chungnam National University hospital
  • Chonnam National university medical school & Hospital
  • hanyang University Guri Hospital
  • Konkuk University Medical Center
  • Chung-Ang University hospital
  • Hanyang University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Imotun

Placebo

Arm Description

300.03mg/cap,orally, 1 capsule once daily for 24 weeks

1 capsule once daily for 24 weeks

Outcomes

Primary Outcome Measures

Change from baseline in the Lequesne's index score at 24weeks
Change from baseline in the Lequesne's index score at 24weekS
100mm Pain VAS
assessment of 100mm Pain VAS (24weekS)

Secondary Outcome Measures

Change from baseline Lequesne's index score at 4weeks
Change from baseline Lequesne's index score at 4weeks
Change from baseline Lequesne's index score at 8weeks
Change from baseline Lequesne's index score at 8weeks
Change from baseline Lequesne's index score at 16weeks
Change from baseline Lequesne's index score at 16weeks
100mm Pain VAS
- Patient's assessment of 100mm Pain VAS
Global assement (Patient, Physician)
-Global assement (Patient, Physician)
administration days of the rescue medication
administration days of the rescue medication
The rate of patients who consumed the rescue medication
The rate of patients who consumed the rescue medication
100mm Pain VAS
- Patient's assessment of 100mm Pain VAS
100mm Pain VAS
- Patient's assessment of 100mm Pain VAS
change from baseline 100mm Pain VAS at 4weeeks
change from baseline 100mm Pain VAS at 4weeeks
change from baseline 100mm Pain VAS at 8weeeks
change from baseline 100mm Pain VAS at 8weeeks
change from baseline 100mm Pain VAS at 16weeeks
change from baseline 100mm Pain VAS at 16weeeks
change from baseline 100mm Pain VAS at 24weeeks
change from baseline 100mm Pain VAS at 24weeeks
Global assement (Patient, Physician)
-Global assement (Patient, Physician)
Global assement (Patient, Physician)
-Global assement (Patient, Physician)
change from baseline Global assement (Patient, Physician)
-Global assement (Patient, Physician)
Global assement (Patient, Physician)
-Global assement (Patient, Physician)
dosing quantity of the rescue medication
dosing quantity of the rescue medication

Full Information

First Posted
October 30, 2012
Last Updated
March 24, 2017
Sponsor
Chong Kun Dang Pharmaceutical
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1. Study Identification

Unique Protocol Identification Number
NCT01756937
Brief Title
Efficacy and Safety of Imotun Capsule in Osteoarthritis of the Knee
Acronym
ABSOLUTE-R
Official Title
A Six-month, Multi Center, Randomizied, Double Blind, Parallel-group,Placebo Controlled Study to Evaluate Efficacy and Safety of Imotun Capsule in Osteoarthritis of the Knee
Study Type
Interventional

2. Study Status

Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
January 2013 (undefined)
Primary Completion Date
October 2016 (Actual)
Study Completion Date
February 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chong Kun Dang Pharmaceutical

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Efficacy and safety of Imotun capsule in osteoarthritis of the knee
Detailed Description
A six-month, multi center, randomizied, double blind, parallel-group,placebo controlled study to evaluate efficacy and safety of Imotun capsule in osteoarthritis of the knee

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis of the Knee
Keywords
osteoarthritis of the knee

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
287 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Imotun
Arm Type
Active Comparator
Arm Description
300.03mg/cap,orally, 1 capsule once daily for 24 weeks
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
1 capsule once daily for 24 weeks
Intervention Type
Drug
Intervention Name(s)
Imotun
Other Intervention Name(s)
Avocado-Soya Unsaponifiables 300.03mg/Cap
Intervention Description
300.03mg/cap,orally, 1 capsule once daily for 24 weeks
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
1 capsule once daily for 24 weeks
Primary Outcome Measure Information:
Title
Change from baseline in the Lequesne's index score at 24weeks
Description
Change from baseline in the Lequesne's index score at 24weekS
Time Frame
baseline, 24 weeks
Title
100mm Pain VAS
Description
assessment of 100mm Pain VAS (24weekS)
Time Frame
24 weeks
Secondary Outcome Measure Information:
Title
Change from baseline Lequesne's index score at 4weeks
Description
Change from baseline Lequesne's index score at 4weeks
Time Frame
baseline, 4 weeks
Title
Change from baseline Lequesne's index score at 8weeks
Description
Change from baseline Lequesne's index score at 8weeks
Time Frame
baseline, 8 weeks
Title
Change from baseline Lequesne's index score at 16weeks
Description
Change from baseline Lequesne's index score at 16weeks
Time Frame
baseline, 16 weeks
Title
100mm Pain VAS
Description
- Patient's assessment of 100mm Pain VAS
Time Frame
4weeks
Title
Global assement (Patient, Physician)
Description
-Global assement (Patient, Physician)
Time Frame
4weeks
Title
administration days of the rescue medication
Description
administration days of the rescue medication
Time Frame
24weeks
Title
The rate of patients who consumed the rescue medication
Description
The rate of patients who consumed the rescue medication
Time Frame
24weeks
Title
100mm Pain VAS
Description
- Patient's assessment of 100mm Pain VAS
Time Frame
8weeks
Title
100mm Pain VAS
Description
- Patient's assessment of 100mm Pain VAS
Time Frame
16weeks
Title
change from baseline 100mm Pain VAS at 4weeeks
Description
change from baseline 100mm Pain VAS at 4weeeks
Time Frame
baseline, 4weeks
Title
change from baseline 100mm Pain VAS at 8weeeks
Description
change from baseline 100mm Pain VAS at 8weeeks
Time Frame
baseline, 8weeks
Title
change from baseline 100mm Pain VAS at 16weeeks
Description
change from baseline 100mm Pain VAS at 16weeeks
Time Frame
baseline, 16 weeks
Title
change from baseline 100mm Pain VAS at 24weeeks
Description
change from baseline 100mm Pain VAS at 24weeeks
Time Frame
baseline, 24 weeks
Title
Global assement (Patient, Physician)
Description
-Global assement (Patient, Physician)
Time Frame
8weeks
Title
Global assement (Patient, Physician)
Description
-Global assement (Patient, Physician)
Time Frame
16weeks
Title
change from baseline Global assement (Patient, Physician)
Description
-Global assement (Patient, Physician)
Time Frame
baseline, 16weeks
Title
Global assement (Patient, Physician)
Description
-Global assement (Patient, Physician)
Time Frame
24weeks
Title
dosing quantity of the rescue medication
Description
dosing quantity of the rescue medication
Time Frame
24weeks
Other Pre-specified Outcome Measures:
Title
Safety assessed by the incidence of adverse event
Description
Safety assessed by the incidence of adverse event
Time Frame
up to 24weeks
Title
laboratory test
Description
laboratory test
Time Frame
up to 24weeks
Title
medication history
Description
medication history
Time Frame
up to 24weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Agreement with written informed consent and 40 years of age and older Patients with more than 63months history of OA of knee according to ACR criteria Radiographic evidence of Kellgren & Lawrence grade II to III OA of the knee The 100mm Pain VAS is over 40mm The Lequensne's index is over 5 Exclusion Criteria: Treatment with SYSADOA within 3 months History of joint surgery within 5 years or Arthroscopic surgery within 1year Intra-articular injections within 3 months Treatment with NASIDs within 7 days Any history of adverse reaction to the study drugs clinically significant hepatic, renal, cardiovascular diseases Patients with gastrointestinal ulcers or bleeding disorders Pregnant women, nursing mothers or Fertile women who not practice contraception with appropriate methods History of drug abuse or alcoholism Patients on any other clinical trial or experimental treatment in the past 4 weeks An impossible one who participates in clinical trial by investigator's decision
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dae Hyun Yoo
Organizational Affiliation
Hanyang University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hallym Universicy Sacred heart Hospital
City
Anyang
ZIP/Postal Code
431-070
Country
Korea, Republic of
Facility Name
Dong-A university Hospital
City
Busan
ZIP/Postal Code
602-715
Country
Korea, Republic of
Facility Name
Yeungnam university medical center
City
Daegu
ZIP/Postal Code
705-035
Country
Korea, Republic of
Facility Name
Chungnam National University hospital
City
Daejon
ZIP/Postal Code
301-721
Country
Korea, Republic of
Facility Name
Chonnam National university medical school & Hospital
City
Gwangju
ZIP/Postal Code
501-757
Country
Korea, Republic of
Facility Name
hanyang University Guri Hospital
City
Gyeonggi-do
Country
Korea, Republic of
Facility Name
Konkuk University Medical Center
City
Seoul
ZIP/Postal Code
143-729
Country
Korea, Republic of
Facility Name
Chung-Ang University hospital
City
Seoul
ZIP/Postal Code
156-755
Country
Korea, Republic of
Facility Name
Hanyang University Hospital
City
Special City of Seoul
Country
Korea, Republic of

12. IPD Sharing Statement

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Efficacy and Safety of Imotun Capsule in Osteoarthritis of the Knee

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